MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2020-03-13 for 3M? MICROPORE? PAPER TAPE N/A 1530-1 manufactured by 3m Health Care.
[183374079]
Reporter occupation not provided. Reported from children's burn unit. No lot number, questionnaire or picture was available. Three attempts have been made to contact customer for additional information. To date, no additional information has been received. It was described that a blister developed presumably in the application area of micropore. Probably upon removal; skin loss was observed. The depth of the wound is unknown; however, skin grafting was alleged to treat the injury. Usually if skin tears appear, only the dermis, sometimes also parts or the complete dermis may be removed. These cases are quite rare and if they appear, they are typically in elderly populations with fragile and atrophic skin may be affected. End of report.
Patient Sequence No: 1, Text Type: N, H10
[183374080]
An eu regulatory authority in (b)(6) reported a customer alleged on (b)(6) 2019 they applied 3m? Micropore? Tape 1530-1 on their child at home. Patient specifics are not available. Location where the tape was applied, the length of time it was on the child and indication was not provided. Symptoms alleged included blistering and full thickness wounds. Unknown if there was difficulty removing the tape. Reporter alleged patient required medical intervention that included debridement and skin graft. Current status of patient was reported as "continuing". History of allergies and skin sensitivities are unknown. No further information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2110898-2020-00008 |
| MDR Report Key | 9829558 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2020-03-13 |
| Date of Report | 2020-03-13 |
| Date of Event | 2019-07-16 |
| Date Mfgr Received | 2019-08-13 |
| Date Added to Maude | 2020-03-13 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DIANNE GIBBS |
| Manufacturer Street | 3M CENTER BUILDING 275-5W-06 |
| Manufacturer City | ST. PAUL, MN |
| Manufacturer Country | US |
| Manufacturer Phone | 7379117 |
| Manufacturer G1 | 3M DEUTSCHLAND GMBH, WERK |
| Manufacturer Street | MANUFACTURING MEDICAL DEVICES EDISONSTRASSE 6 |
| Manufacturer City | KAMEN, 59174 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 59174 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3M? MICROPORE? PAPER TAPE |
| Generic Name | TAPE AND BANDAGE, ADHESIVE |
| Product Code | KGX |
| Date Received | 2020-03-13 |
| Model Number | N/A |
| Catalog Number | 1530-1 |
| Lot Number | UNK |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M HEALTH CARE |
| Manufacturer Address | 2510 CONWAY AVE ST. PAUL, MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-13 |