3M™ Durapore™ 1538-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 30707387007424), received between Jan 25, 2019 and Jan 28, 2019 — classified as 2 injuries.

The most frequently reported specific device problem is “Use of Device Problem” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJan 28, 2019Use of Device Problem; Use of Device Problem

  A NURSE IN (B)(6) REPORTED A PEDIATRIC PATIENT EXPERIENCED A SKIN INJURY WITH USE OF 1538-1 DURAPORE¿ SURGICAL TAPE. THE PATIENT EXPERIENCED WHITE SKIN (MACERATION) WITH EDEMA ON THE BACK OF THEIR RIGHT HAND. MEDICAL TREATMENT WAS NOT SPECIFIED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Edema; No Code Available

  MAUDE report 8282381 ↗
• InjuryJan 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN OUTPATIENT DIALYSIS CLINIC REPORTED THE FOLLOWING INFORMATION. PATIENT ARRIVED TO TREATMENT ALERT AND ORIENTED. PRE-DIALYSIS VITAL SIGNS OBTAINED: B/P: 152/77; PULSE 73; RESP 20; TEMP 97.6. TREATMENT WAS INITIATED AT 13:21, AND VITAL SIGNS CHECKED EVERY 20 MINUTES. AT 14:01. B/P WAS 128/68; PULSE 75. APPROXIMATELY 8 MINUTES LATER, THE MACHINE ALARMED. THE PATIENT WAS FOUND UNRESPONSIVE WITH THE TIP OF THE VENOUS NEEDLE DISLODGED. TAPE WAS STILL INTACT ON THE PATIENT'S SKIN. LARGE AMOUNTS OF BLOOD WERE NOTED ON THE FLOOR. EBL 300-400ML. THE VENOUS LINE WAS CLAMPED, AND PRESSURE APPLIED TO THE VENOUS CANNULATION SITE. BLOOD WAS RETURNED VIA THE ARTERIAL NEEDLE, AND NORMAL SALINE WAS ADMINISTERED VIA THE ARTERIAL NEEDLE; APPROXIMATELY 800 ML NORMAL SALINE WAS ADMINISTRATED. OXYGEN WAS APPLIED VIA MASK AT 3 LPM. AED PADS PLACED ON CHEST, CPR INITIATED. 911 WAS CALLED. THE PATIENT STARTED SPONTANEOUSLY BREATHING AT 14:13. VS UPON DISCHARGE FROM FACILITY: B/P 156/99; PULSE 102; RESP 23 TEMP 97.8. THE PATIENT WAS TRANSPORTED TO THE HOSPITAL VIA EMS AND ADMITTED. PATIENT WAS TRANSFUSED WITH 3 U PRBCS DURING HOSPITALIZATION AND WAS DISCHARGED (B)(6) 2019, RETURNING TO THE FACILITY FOR HE

  Patient problems: Blood Loss; Cardiopulmonary Arrest; Hypovolemia

  MAUDE report 8279744 ↗