GalaFLEX Scaffold 100035-15Recalls & reported problems

Summary

The FDA's MAUDE database contains 64 adverse event reports that list this exact device (DI 00855920006034), received between Mar 9, 2022 and Jun 5, 2024 — classified as 62 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (63 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 64 reports, in the reporter's own words as published by the FDA.

• InjuryJun 5, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, THE PATIENT UNDERWENT A BREAST AUGMENTATION WITH MASTOPEXY PROCEDURE WITH IMPLANT OF GALAFLEX ON (B)(6) 2021 AND REPORTED ¿GALAFLEX DID NOT WORK. THE PATIENT¿S TISSUE IS STILL WEAK AND MUST REDO HER PROCEDURE USING MORE GALAFLEX." IT WAS REPORTED THAT MESH WAS "BOTTOMING OUT (NO SUPPORT) APPROXIMATELY 1 YEAR AFTER SURGERY." IT WAS ALSO REPORTED THAT PATIENT IS "HEALTHY, ONLY TAKES VITAMINS."

  Patient problems: Physical Asymmetry

  MAUDE report 19467426 ↗
• InjuryMar 23, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, PATIENT WHO HAD A HISTORY OF HEAVY SMOKING WAS DIAGNOSED WITH LARGE HEMATOMA ON RIGHT SIDE OF THE BREAST AND UNDERWENT RIGHT SIDE UNILATERAL BREAST REPAIR SURGERY (IMPLANT REMOVAL, CAPSULECTOMY, AND IMPLANT REPLACEMENT) WITH THE IMPLANT OF GALAFLEX ON (B)(6) 2022. IT WAS REPORTED THAT OVER 3 MONTHS LATER, PATIENT COULD FEEL THE GALAFLEX MESH AND IT DID NOT COMPLETELY INCORPORATE.

  Patient problems: Breast Discomfort/Pain

  MAUDE report 16598986 ↗
• InjuryNov 2, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  PER CLINICAL TRIAL (B)(4): ON (B)(6) 2019, PATIENT UNDERWENT ABDOMINAL VENTRAL HERNIA REPAIR, DUE TO LARGE VENTRAL ABDOMINAL HERNIA FOUND DURING TUMMY TUCK. INCISION TYPE WAS SUBFASCIAL DISSECTION CIRCUMFERENTIAL TO THE DEFECT (PERIUMBILICAL VENTRAL HERNIA). CONCOMITANT PROCEDURE WAS ABDOMINOPLASTY. ONE PIECE OF GALAFLEX WAS USED. ON (B)(6) 2019, DELAYED WOUND HEALING; ABDOMEN WAS REPORTED. THIS AE WAS ASSESSED BY THE CLINICIAN TO BE SEVERE AND A SERIOUS ADVERSE EVENT. PATIENT HAD MULTIPLE DEBRIDEMENT, AND LOCAL WOUND CARE. RESOLVED WITH SEQUELAE ON (B)(6) 2019. POSSIBLY REVISE UMBILICUS IN THE FUTURE. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE DELAYED WOUND HEALING AS LIKELY RELATED TO THE DEVICE AND SERIOUS.

  Patient problems: Impaired Healing

  MAUDE report 15713416 ↗
• InjuryNov 2, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  PER CLINICAL TRIAL (B)(4): ON (B)(6) 2016, PATIENT UNDERWENT BILATERAL BREAST REDUCTION; SUPERIOR PEDICLE, USING A FULL VERTICAL AND HORIZONTAL T INCISION. TWO PIECES OF GALAFLEX WERE USED AND CUT IN AN ELLIPTICAL SHAPE. CONCOMITANT PROCEDURE WAS LIPOSUCTION OF AXILLA. ON (B)(6) 2016, LEFT BREAST INFECTION (MRSA) WAS REPORTED. PATIENT WAS TREATED WITH IV ANTIBIOTIC (DAPTOMYCIN, FOR APPROX. 3 WEEKS) AND OTHER MEDICATIONS (KEFLEX, DOXYCYCLINE, VICOPASTE). REVIEW OF MEDICAL AFFAIRS IDENTIFIED THAT THE INFECTION IS LIKELY RELATED TO THE DEVICE AND SERIOUS.

  Patient problems: Bacterial Infection

  MAUDE report 15713374 ↗
• InjuryAug 2, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  PER CLINICAL TRIAL CP-1060: ON (B)(6) 2015 PATIENT HAD BILATERAL REVISION AUGMENTATION MASTOPEXY USING A PERIAREOLAR AND VERTICAL INCISION. 1 PIECE OF GALAFLEX CUT IN FOOTBALL SHAPE, WAS USED. CONCOMITANT PROCEDURES WERE UPPER AND LOWER BLEPHAROPLASTY AND FAT GRAFTING TO FACE. ON (B)(6) 2015 BREAST ASYMMETRY AND IMPLANT POCKET HERNIATION WAS REPORTED. ON (B)(6) 2015 PATIENT UNDERWENT BILATERAL LATERAL AND INFERIOR CAPSULORRHAPHY PROCEDURE USING 2 NEW PIECES OF GALAFLEX MESH, CUT ELLIPTICALLY, AND REVISION OF INFRAMAMMARY INCISION WITH EXCISION OF ADDITIONAL REDUNDANT SKIN. RESOLVED WITHOUT SEQUELAE ON (B)(6) 2015 . REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE REPORTED AE IS LIKELY RELATED TO THE DEVICE AND SERIOUS.

  Patient problems: Hernia; Physical Asymmetry

  MAUDE report 15145009 ↗
• InjuryJul 12, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  PER CLINICAL TRIAL (B)(6): ON (B)(6) 2016, PATIENT UNDERWENT BILATERAL REVISION MASTOPEXY/REDUCTION; SUPERIOR PEDICLE USING A VERTICAL INCISION. 1 PIECE OF GALAFLEX WAS CUT INTO AN ELLIPTICAL SHAPE. CONCOMITANT PROCEDURES INCLUDED MASTOPEXY/CAPSULORRHAPHY, FAT GRAFTING, FRACTIONAL CO2 LASER, UPPER AND LOWER BLEPHAROPLASTY. ON (B)(6) 2016, CYANOTIC TISSUE; RIGHT BREAST WAS REPORTED. PATIENT WAS TREATED WITH MEDICATION (NITROBID). RESOLVED WITHOUT SEQUELAE ON (B)(6) 2016. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE CYANOTIC TISSUE AS LIKELY RELATED TO THE DEVICE AND SERIOUS.

  Patient problems: Cyanosis

  MAUDE report 14984993 ↗
• InjuryJul 6, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  PER CLINICAL TRIAL CP-1060: ON 4/15/15, PATIENT UNDERWENT BILATERAL AUGMENTATION MASTOPEXY USING A FULL VERTICAL AND HORIZONTAL T INCISION. 1 PIECE OF GALAFLEX WAS USED, CUT IN HALF. NO CONCOMITANT PROCEDURES WERE DONE. ON 5/21/15, DRAINAGE; BREAST, WAS REPORTED. PATIENT WAS TREATED WITH MEDICATION (KEFLEX, BACTROBAN OINTMENT). UNKNOWN END DATE, AS PATIENT NEVER RETURNED FOR FOLLOW UP. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE REPORTED ADVERSE EVENT AS LIKELY RELATED TO THE DEVICE AND SERIOUS.

  Patient problems: Fluid Discharge

  MAUDE report 14938517 ↗
• InjuryJul 6, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  PER CLINICAL TRIAL (B)(6): ON (B)(6) 2014, PATIENT UNDERWENT BILATERAL REVISION MASTOPEXY; INFERIOR PEDICLE, USING A FULL VERTICAL AND HORIZONTAL T INCISION. 1 PIECE OF GALAFLEX WAS USED, CUT IN HALF. CONCOMITANT PROCEDURE INCLUDED UMBILICAL HERNIA REPAIR. ON (B)(6) 2014, BREAST INFECTION WAS REPORTED. PATIENT WAS TREATED WITH MEDICATION (CIPRO, BACTRIM). RESOLVED WITHOUT SEQUELAE ON (B)(6) 2015. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE BREAST INFECTION AS LIKELY RELATED TO THE DEVICE AND SERIOUS.

  Patient problems: Unspecified Infection

  MAUDE report 14938410 ↗
• InjuryJul 6, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  PER CLINICAL TRIAL (B)(4): ON (B)(6) 2014, PATIENT UNDERWENT BILATERAL MASTOPEXY; INFERIOR PEDICLE, USING A FULL VERTICAL AND HORIZONTAL T INCISION. 1 PIECE OF GALAFLEX WAS USED, CUT IN HALF. THERE WERE NO CONCOMITANT PROCEDURES DONE. ON (B)(6) 2014, ERYTHEMA/REDNESS; BREAST WAS REPORTED. PATIENT WAS TREATED WITH MEDICATION (CIPRO). RESOLVED WITHOUT SEQUELAE ON (B)(6) 2014. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE ERYTHEMA AS LIKELY RELATED TO THE DEVICE AND SERIOUS.

  Patient problems: Erythema

  MAUDE report 14938394 ↗
• InjuryJul 6, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  PER CLINICAL TRIAL (B)(6): ON (B)(6) 2014, PATIENT UNDERWENT BILATERAL BREAST REDUCTION; INFERIOR PEDICLE, USING A FULL VERTICAL AND HORIZONTAL T INCISION. 1 PIECE OF GALAFLEX WAS USED AND CUT IN HALF. THERE WERE NO CONCOMITANT PROCEDURES DONE. ON (B)(6) 2014, EPIDERMOLYSIS; BREAST, WAS REPORTED. PATIENT WAS TREATED WITH MEDICATION (EUCERIN OINTMENT). RESOLVED WITHOUT SEQUELAE ON (B)(6) 2015. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE EPIDERMOLYSIS AS LIKELY RELATED TO THE DEVICE AND NOT SERIOUS.

  Patient problems: Skin Disorders

  MAUDE report 14938325 ↗
• InjuryJul 6, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  PER CLINICAL TRIAL CP-1060: ON (B)(6) 2014, PATIENT UNDERWENT BILATERAL MASTOPEXY; INFERIOR PEDICLE, USING A FULL VERTICAL AND HORIZONTAL T INCISION. 1 PIECE OF GALAFLEX WAS USED, CUT IN HALF. THERE WERE NO CONCOMITANT PROCEDURES DONE. ON(B)(6) 2014, BREAST HEMATOMA WAS REPORTED. HEMATOMA WAS EVACUATED ON (B)(6) 2014. RESOLVED WITHOUT SEQUELAE ON (B)(6) 2014. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE BREAST HEMATOMA AS LIKELY RELATED TO THE DEVICE AND SERIOUS.

  Patient problems: Hematoma

  MAUDE report 14937854 ↗
• InjuryJun 24, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  PER CLINICAL TRIAL (B)(4): ON (B)(6) 2015, PATIENT UNDERWENT BILATERAL MASTOPEXY; INFERIOR PEDICLE, USING A FULL VERTICAL AND HORIZONTAL T INCISION. 1 PIECE OF GALAFLEX WAS USED, CUT IN HALF. NO CONCOMITANT PROCEDURES WERE DONE. ON (B)(6) 2015, SWELLING; BREAST, WAS REPORTED. PATIENT WAS TREATED WITH MEDICATION (BACTRIM). RESOLVED WITHOUT SEQUELAE ON (B)(6) 2015. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE POSTOPERATIVE SWELLING AS LIKELY RELATED TO THE DEVICE AND SERIOUS.

  Patient problems: Swelling/ Edema

  MAUDE report 14799706 ↗
• InjuryJun 24, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  PER CLINICAL TRIAL (B)(6): ON (B)6) 2015, PATIENT UNDERWENT BILATERAL MASTOPEXY; INFERIOR PEDICLE, USING A FULL VERTICAL AND HORIZONTAL T INCISION. 1 PIECE OF GALAFLEX WAS USED, CUT IN HALF. NO CONCOMITANT PROCEDURES WERE DONE. ON (B)(6) 2015, RIGHT BREAST HEMATOMA WAS REPORTED. ON (B)(6) 2015, PATIENT HAD EVACUATION OF HEMATOMA. RESOLVED WITHOUT SEQUELAE ON (B)(6) 2015. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE HEMATOMA AS LIKELY RELATED TO THE DEVICE AND SERIOUS.

  Patient problems: Hematoma

  MAUDE report 14799665 ↗
• InjuryJun 24, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  PER CLINICAL TRIAL (B)(4): ON (B)(6) 2016, PATIENT UNDERWENT BILATERAL AUGMENTATION MASTOPEXY USING A FULL VERTICAL AND HORIZONTAL T INCISION. 1 PIECE OF GALAFLEX WAS USED, CUT IN HALF. CONCOMITANT PROCEDURES INCLUDED ABDOMINOPLASTY AND LIPOSUCTION. ON (B)(6)2016, ERYTHEMA/REDNESS; BREAST WAS REPORTED. PATIENT WAS TREATED WITH MEDICATION (KEFLEX, BACTROBAN). RESOLVED WITHOUT SEQUELAE ON (B)(6) 2016. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE REPORTED ADVERSE EVENT AS LIKELY RELATED TO THE DEVICE AND SERIOUS.

  Patient problems: Erythema

  MAUDE report 14799534 ↗
• InjuryJun 24, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  PER CLINICAL TRIAL (B)(4): ON (B)(6) 2016, PATIENT UNDERWENT BILATERAL AUGMENTATION MASTOPEXY USING A FULL VERTICAL AND HORIZONTAL T INCISION. 1 PIECE OF GALAFLEX WAS USED AND CUT IN HALF. CONCOMITANT PROCEDURE WAS A NIPPLE REDUCTION. ON (B)(6) 2016, DRAINAGE; BREAST, WAS REPORTED. PATIENT WAS TREATED WITH MEDICATION (BACTRIM, BACTROBAN). RESOLVED WITHOUT SEQUELAE ON (B)(6) 2016. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE WOUND DRAINAGE AS LIKELY RELATED TO THE DEVICE AND SERIOUS.

  Patient problems: Fluid Discharge

  MAUDE report 14799527 ↗
• InjuryJun 24, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  PER CLINICAL TRIAL (B)(4): ON (B)(6) 2017, PATIENT UNDERWENT BILATERAL REVISION AUGMENTATION; LOWER POLE BOTTOMING OUT (LOWER POLE STRETCH DEFECT) USING A SHORT SCAR INCISION. 1 PIECE OF GALAFLEX WAS USED, CUT IN HALF. THERE WERE NO CONCOMITANT PROCEDURES DONE. ON (B)(6) 2017, CAPSULAR CONTRACTURE OF LEFT BREAST WAS REPORTED. ON (B)(6) 2017, PATIENT HAD LEFT BREAST REVISION AUGMENTATION FOR CAPSULAR CONTRACTURE, USING P4HB.1 NEW PIECE OF GALAFLEX WAS USED ON THE LEFT BREAST. RESOLVED WITHOUT SEQUELAE ON (B)(6) 2017. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE CAPSULAR CONTRACTURE AS RELATED TO THE DEVICE AND SERIOUS.

  Patient problems: Capsular Contracture

  MAUDE report 14799492 ↗
• InjuryJun 24, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  PER CLINICAL TRIAL (B)(4): ON (B)(6) 2017, PATIENT UNDERWENT BILATERAL BREAST AUGMENTATION USING A SHORT SCAR INCISION. 1 PIECE OF GALAFLEX WAS USED, CUT IN HALF. CONCOMITANT PROCEDURE INCLUDED CORRECTION OF FOLD MALPOSITION. ON (B)(6) 2017, RIGHT BREAST HEMATOMA WAS REPORTED. PATIENT HAD HEMATOMA EVACUATION ON (B)(6) 2017. SECOND EXPLORATION OF RIGHT BREAST DONE ON 5/5/17. RESOLVED WITHOUT SEQUELAE ON (B)(6) 2017. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE REPORTED HEMATOMA IS LIKELY RELATED TO THE DEVICE AND SERIOUS.

  Patient problems: Hematoma

  MAUDE report 14799307 ↗
• InjuryJun 15, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  PER CLINICAL TRIAL (B)(4): ON (B)(6) 2016, PATIENT UNDERWENT BILATERAL REVISION AUGMENTATION; CAPSULAR CONTRACTURE, USING AN IMF INCISION. 2 PIECES OF GALAFLEX (DEVICE #1 AND DEVICE #2) WERE USED. CONCOMITANT PROCEDURE INCLUDED BILATERAL CAPSULECTOMY. ON (B)(6) 2016, BILATERAL BREAST SEROMAS WERE REPORTED. REPORTED AS SAE. PATIENT HAD ASPIRATION OF BOTH SEROMAS ON (B)(6) 2016 AND (B)(6) 2016. PATIENT WAS ALSO TREATED WITH MEDICATION (KEFLEX 500MG). WEARING POST SURGICAL BANDEAU BRA. RESOLVED WITHOUT SEQUELAE ON (B)(6) 2016. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE ADVERSE EVENT AS LIKELY RELATED TO THE DEVICE AND SERIOUS.

  Patient problems: Seroma

  MAUDE report 14693644 ↗
• InjuryJun 15, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  PER CLINICAL TRIAL (B)(4): ON (B)(6) 2016, PATIENT UNDERWENT BILATERAL REVISION AUGMENTATION; CAPSULAR CONTRACTURE, USING AN IMF INCISION. 2 PIECES OF GALAFLEX (DEVICE #1 AND DEVICE #2) WERE USED. CONCOMITANT PROCEDURE INCLUDED BILATERAL CAPSULECTOMY. ON (B)(6) 2016, BILATERAL BREAST SEROMAS WERE REPORTED. REPORTED AS SAE. PATIENT HAD ASPIRATION OF BOTH SEROMAS ON (B)(6) 2016 AND (B)(6) 2016. PATIENT WAS ALSO TREATED WITH MEDICATION (KEFLEX 500MG). WEARING POST SURGICAL BANDEAU BRA. RESOLVED WITHOUT SEQUELAE ON (B)(6) 2016. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE ADVERSE EVENT AS LIKELY RELATED TO THE DEVICE AND SERIOUS.

  Patient problems: Seroma

  MAUDE report 14693613 ↗
• InjuryJun 8, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  PER CLINICAL TRIAL CP-1060: ON (B)(6) 2018, PATIENT UNDERWENT BILATERAL BREAST REDUCTION; MEDIAL PEDICLE USING A WISE PATTERN SUPEROMEDIAL PEDICLE INCISION. 2 PIECES OF GALAFLEX WERE USED. ON (B)(6) 2018, BILATERAL BREAST SEROMA WAS REPORTED. SAE. ON (B)(6) 2018, PATIENT HAD ASPIRATION OF SEROMAS. SEROSANGUINOUS DRAINAGE ASPIRATED FROM BOTH BREASTS OVER SEVERAL DATES. RESOLVED WITHOUT SEQUELAE ON 6/5/18. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE REPORTED SEROMA IS LIKELY RELATED TO THE DEVICE AND SERIOUS.

  Patient problems: Seroma

  MAUDE report 14636704 ↗
• InjuryJun 7, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  PER CLINICAL TRIAL (B)(4): ON (B)(6) 2015, PATIENT UNDERWENT BILATERAL BREAST MASTOPEXY; SUPERIOR PEDICLE USING AN INCISION DESCRIBED AS OTHER: AREOLA, WISE PATTERN SUPERIOR PEDICLE. 2 PIECES OF GALAFLEX WERE USED. CONCOMITANT PROCEDURES INCLUDED FAT HARVESTING FROM ABS AND HIPS, FAT GRAFTING TO BREASTS, CORONAL BROWLIFT. ON (B)(6) 2015, LEFT BREAST SEROMA WAS REPORTED. ON (B)(6) 2015, PATIENT HAD SEROMA ASPIRATION (20CC) AND SEROMA CATHETER PLACED. ALSO, TREATED WITH MEDICATION (KEFLEX). RESOLVED ON (B)(6) 2015 WITHOUT SEQUELAE. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE REPORTED SEROMA IS LIKELY RELATED TO THE DEVICE AND SERIOUS.

  Patient problems: Seroma

  MAUDE report 14622104 ↗
• InjuryJun 7, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  PER CLINICAL TRIAL (B)(6) : ON (B)(6) 2016 PATIENT UNDERWENT BILATERAL MASTOPEXY/AUGMENTATION/REDUCTION USING A FULL VERTICAL AND HORIZONTAL T INCISION. 2 PIECES OF GALAFLEX WERE USED. NO CONCOMITANT PROCEDURES WERE DONE. ON (B)(6) 2016, ERYTHEMA/REDNESS, RIGHT TRIFURCATION WAS REPORTED. ON (B)(6) 2016, PATIENT HAD RIGHT INFERIOR AREOLA DEBRIDEMENT AND WAS TREATED WITH MEDICATION (KEFLEX, SILVADENE 1%). RESOLVED WITHOUT SEQUELAE ON (B)(6) 2016. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE REPORTED ERYTHEMA/REDNESS IS LIKELY RELATED TO THE DEVICE AND SERIOUS.

  Patient problems: Erythema

  MAUDE report 14622056 ↗
• InjuryJun 7, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  PER CLINICAL TRIAL (B)(6) : ON (B)(6) 2015 PATIENT UNDERWENT BILATERAL REVISION AUGMENTATION; PTOSIS USING A VERTICAL INCISION. 2 PIECES OF GALAFLEX WERE USED. CONCOMITANT PROCEDURE WAS MASTOPEXY. ON (B)(6) 2015 ALLERGIC REACTION (UNKNOWN BODY LOCATION) WAS REPORTED. RASH, HIVES, ITCHING. PATIENT TOLD TO STOP ANTIBIOTIC. PATIENT TREATED WITH MEDICATION (MEDROL DOSE PACK 4MG). RESOLVED WITHOUT SEQUELAE ON UNKNOWN DATE. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE REPORTED AE IS LIKELY RELATED TO THE DEVICE AND SERIOUS.

  Patient problems: Hypersensitivity/Allergic reaction; Itching Sensation; Rash

  MAUDE report 14622033 ↗
• InjuryJun 7, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  PER CLINICAL TRIAL (B)(6). ON (B)(6) 2015 , PATIENT UNDERWENT BILATERAL AUGMENTATION MASTOPEXY USING A FULL VERTICAL AND HORIZONTAL T INCISION. 2 PIECES OF GALAFLEX WERE USED (DEVICE #1 AND DEVICE #2). CONCOMITANT PROCEDURES INCLUDED ABDOMINOPLASTY AND REPAIR OF PERIUMBILICAL HERNIA. ON (B)(6) 2015 , NERVE, VESSEL OR STRUCTURE DAMAGE; RIGHT AREOLA, WAS REPORTED. PATIENT WAS TREATED WITH MEDICATION (NITROPASTE). RESOLVED WITHOUT SEQUELAE ON (B)(6) 2015. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE REPORTED AE IS LIKELY RELATED TO THE DEVICE AND SERIOUS.

  Patient problems: Nerve Damage

  MAUDE report 14622031 ↗
• InjuryJun 7, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  PER CLINICAL TRIAL (B)(4): ON (B)(6) 2015, PATIENT UNDERWENT BILATERAL AUGMENTATION MASTOPEXY USING A FULL VERTICAL AND HORIZONTAL T INCISION. 1 PIECE OF GALAFLEX WAS USED. CONCOMITANT PROCEDURE INCLUDED EXCISION OF RIGHT ABDOMINAL SCAR. ON (B)(6) 2015, ALLERGIC REACTION ALL OVER BODY, WAS REPORTED. PATIENT WAS TREATED WITH MEDICATION (STOPPED KEFLEX AND PERCOCET AND PLACED ON MEDROL DOSE PACK). PATIENT WENT TO ER WITH LIP SWELLING AND HIVES ON (B)(6) 2015. TREATED WITH HYDROXYZINE AND FAMOTIDINE. ALL RESOLVED WITHOUT SEQUELAE ON (B)(6) 2015. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE ADVERSE EVENT AS LIKELY RELATED TO THE DEVICE AND SERIOUS.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 14622023 ↗