N/A 4406Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10885403473142), received between Feb 16, 2021 and Jul 30, 2026 — classified as 2 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (5 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryJul 30, 2026Patient-Device Incompatibility

  As reported, during pre-operative preparation with the Clipper the patient has a laceration right upper thigh close to groin. The patient arrived in pre-op with this wound. No treatment was required as patients proceeded directly to surgery, where standard prophylactic antibiotics and cleansing were performed.

  Patient problems: Laceration(s)

  MAUDE report 50081146 ↗
• MalfunctionMar 30, 2026Patient-Device Incompatibility

  AS REPORTED, IT IS ALLEGED THAT A PATIENT'S HAIR WAS PULLED AND SCRAPPED SKIN. NICKED AREA WAS NEAR THE TUNNEL CATHETER WAS BEING PLACED SO IT WAS BANDAGED WITH THE CATHETER SITE.

  Patient problems: Laceration(s)

  MAUDE report 24709532 ↗
• MalfunctionMar 30, 2026Patient-Device Incompatibility

  AS REPORTED, IT IS ALLEGED THAT THE BD BLADE CUTTING THE PATIENTS. IT WAS REPORTED THAT SEVERAL PATIENT'S HAIR WAS PULLED AND SCRAPPED SKIN. NO SPECIFIC INTERVENTION / ACTION WAS REPORTED TO BE TAKEN.

  Patient problems: Laceration(s)

  MAUDE report 24709527 ↗
• MalfunctionMar 30, 2026Patient-Device Incompatibility

  AS REPORTED, IT IS ALLEGED THAT THE BD BLADE CUTTING THE PATIENTS. IT WAS REPORTED THAT SEVERAL PATIENT'S HAIR WAS PULLED AND SCRAPPED SKIN. NO SPECIFIC INTERVENTION / ACTION WAS REPORTED TO BE TAKEN.

  Patient problems: Laceration(s)

  MAUDE report 24709491 ↗
• MalfunctionOct 8, 2025Patient-Device Incompatibility; Sharp Edges; Patient-Device Incompatibility; Sharp Edges

  IT WAS REPORTED THAT A VERY EXPERIENCED CNA CLIPPED THE PATIENT AND CAUSED A SMALL AMOUNT OF BLEEDING IN THE SURGICAL SITE. THESE RAZORS/CLIPPERS WERE REPORTED TO BE DANGEROUS, TIME CONSUMING, AND INEFFECTIVE.

  Patient problems: Laceration(s)

  MAUDE report 23244625 ↗
• MalfunctionApr 8, 2025Sharp Edges; Sharp Edges

  AS REPORTED, THE BLADE WAS EXTREMELY SHARP, CAUSED INJURY TO PATIENT'S SKIN, SKIN WAS RED AND HAD LESION.

  Patient problems: Erythema; Localized Skin Lesion

  MAUDE report 21800850 ↗
• MalfunctionApr 8, 2025Sharp Edges; Sharp Edges

  AS REPORTED, THE BLADE WAS EXTREMELY SHARP, CAUSED INJURY TO PATIENT'S SKIN, SKIN WAS RED AND HAD LESION.

  Patient problems: Erythema; Localized Skin Lesion

  MAUDE report 21800849 ↗
• MalfunctionJan 8, 2025Sharp Edges; Sharp Edges

  DERMABRASION OBSERVED ON THE PATIENT'S ABDOMEN.

  Patient problems: Abrasion

  MAUDE report 21105514 ↗
• MalfunctionSep 12, 2024

  WHILE PREPARING THE PATIENT FOR SURGERY, THE SHAVER BLADE WAS FOUND TO BE DULL, CAUSING THE PATIENT TO HAVE AN ABRASION TO THE AREA BEING PREPPED.

  Patient problems: Abrasion

  MAUDE report 20199184 ↗
• MalfunctionFeb 26, 2024Sharp Edges; Sharp Edges

  DERMABRASION DURING SHAVING OF THE SURGICAL AREA FOLLOWING USE OF THE CLIPPER BLADE. CONSEQUENCE: SURGERY CANCELLED DUE TO INCREASED RISK OF INFECTION. ANGER OF PATIENT AND SURGEON, DELAYED TREATMENT. RISK OF COMPLAINTS BY THE PATIENT ACCORDING TO HIS OWN WORDS, AGGRESSIVE COMMENTS TOWARDS THE TEAM, THREATENING COMMENTS. SEVERITY 3 - SEVERE. IMMEDIATE ACTION(S): CALL FROM SURGEON EXPRESSING DISSATISFACTION FILE RETURNED TO PATIENT AS HE WISHES TO BE TREATED IN ANOTHER ESTABLISHMENT. SNACK GIVEN BEFORE DEPARTURE, ATTEMPT AT DISCUSSION IMPOSSIBLE WITH (E PATIENT GIVEN HIS VIRULENCE. MANAGER INFORMED OF SITUATION. TRANSMISSIONS OF PATIENT FILE ON D-O (DXCARE).

  Patient problems: Abrasion

  MAUDE report 18778361 ↗
• MalfunctionMay 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE HAS BEEN AN INCREASE IN CLIPPER RAZOR BURNS. VERBATIM: INDICATES THAT THEY HAVE SEEN AN INCREASE IN CLIPPER RAZOR BURNS AND ASKED FOR A REFRESHER ON PROPER AND SAFE USE FOR THE STAFF WHO CLIPS PATIENTS PRIOR TO SURGERY.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 14427922 ↗
• MalfunctionMar 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED SHARP. EMAIL VERBATIM: MULTIPLE CLIPPER INJURIES TO PATIENTS IN THE PRE-OP DEPT. OF HOSPITAL. NO CHANGES IN STAFF, THE SAME NURSES HAVE BEEN CLIPPING FOR 4 AND MORE YEARS. LOT NUMBER 1021 RESULTED IN A HANDFUL OF NICKS, CUTS, AND ABRASIONS ON PATIENTS.

  Patient problems: Abrasion

  MAUDE report 13726061 ↗
• MalfunctionJan 6, 2022Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  MATERIAL NO.: 4406, BATCH NO.: UNKNOWN. IT WAS REPORTED THAT BLADE NIC'D PATIENTS SEVERELY. VERBATIM: SRG BD SURGICAL CLIPPER USED WITH GENERAL PURPOSE BLADE NIC'D PATIENTS SEVERLY.

  Patient problems: Abrasion

  MAUDE report 13180319 ↗
• MalfunctionJan 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT CLIPPER BLADE WAS MISSING ONE OF THE TEETH AND BLADE. VERBATIM: I AM WORKING WITH DIRECTOR OF SURGICAL SERVICES TO OBTAIN MORE DETAILS AND SEE ABOUT GETTING THE SAMPLE. APPARENTLY, ONE OF OUR CLIPPER BLADES WAS MISSING ONE OF THE TEETH ON THE BLADE. THIS LED TO PATIENT HARM PER THE CP MANAGER. I HAVE NOT SEEN THE PRODUCT OR TALKED WITH A CLINICIAN WHO LEADS THE DEPARTMENT. I TALKED TO HER BRIEFLY ON THE MORNING OF 10 DECEMBER, SHE ASKED THAT I CALL HER BACK LATER IN THE DAY, AT 9:30AM. I CALLED BACK AND LEFT A MESSAGE AT THAT TIME. I WILL VISIT THE ACCOUNT MONDAY MORNING.

  Patient problems: Abrasion

  MAUDE report 13154062 ↗
• InjuryAug 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE SALES REPRESENTATIVE THAT THE PATIENT EXPERIENCED A RASH ALLERGIC REACTION PRIOR TO SURGERY. CUSTOMER WAS IN PRE-OP PREPPING THE PATIENT FOR SURGERY. WHEN CUSTOMER STARTED TO USE OUR GENERAL BLADE CLIPPERS THE PATIENT START TO BREAK OUT IN A RASH. CUSTOMER SAID THE PATIENT DID SEEM TO HAVE SENSITIVE SKIN AND POSSIBLE ALLERGY. IT GOT WORSE IN THE OR SO THEY HAD TO TREAT REACTION PRIOR TO SURGERY.

  Patient problems: Rash

  MAUDE report 12385689 ↗
• MalfunctionMar 31, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MATERIAL NO.: 4406. BATCH NO.: UNKNOWN. IT WAS REPORTED A LARGE AREA OF REDNESS, IRRITATION, AND ABRASIONS ON THE PATIENT'S ABDOMEN. PER EMAIL: I'M REACHING OUT TO REPORT A PRODUCT COMPLAINT/INCIDENT THAT HAPPENED AT SURGERY. PEASE SEE THE BELOW INFORMATION FOR DETAILS. I'M WORKING TO GET A PHOTO OF THE PATIENT FROM THE CUSTOMER. I'VE ALREADY HAD A FOLLOW UP MEETING AND PERFORMED ADDITIONAL EDUCATION WITH THE CUSTOMER. ITEM # 5513E AND 4406. DATE OF INCIDENT: (B)(6) 2021. A LARGE AREA OF REDNESS, IRRITATION, AND ABRASIONS ON THE PATIENT'S ABDOMEN OMITTED. FOLLOW UP INFORMATION RECEIVED ON 3/3/2021, STATED THE FOLLOWING, MAKING THIS A REPORTABLE EVENT. I DO NOT HAVE THE SPECIFIC LOT #. THE CUSTOMER HAS A PHOTO OF THE AFFECTED PATIENT AREA, BUT THEY ARE WAITING FOR THEIR QUALITY TEAM TO DETERMINE IF THEY ARE ALLOWED TO SEND IT TO ME. THE CASE WAS CANCELED DUE TO THE SIGNIFICANT IRRITATION OF THE SKIN.

  Patient problems: Abrasion

  MAUDE report 11600616 ↗
• MalfunctionFeb 16, 2021Labelling, Instructions for Use or Training Problem; Inaccurate Information; Labelling, Instructions for Use or Training Problem; Inaccurate Information

  FALSE EXPIRATION DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 11335114 ↗