MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-06-20 for 3M STERI-STRIP SKIN CLOSURES (REINFORCED) R1547 manufactured by 3m Health Care.
[2118840]
Patient suffered excoriations, blisters and skin stripping under steri-strips (b)(6) after a knee prosthesis surgery. A reaction occurred after the first application. Leakage was noted. It was difficult to remove the product and the patient experienced discomfort. It is not known when the skin reaction went away. Medical treatment was not required and no medication was prescribed. Skin was prepped with povidone iodine followed by alcohol and normal saline solution. The patient's skin was dry prior to the application and other wound care products were not used. The current status of the patient was reported as unknown.
Patient Sequence No: 1, Text Type: D, B5
[9168802]
Method: testing not performed. Results: product not returned. Conclusions: no evaluation will be performed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2110898-2011-00079 |
| MDR Report Key | 2142320 |
| Report Source | 05 |
| Date Received | 2011-06-20 |
| Date of Report | 2011-04-11 |
| Date of Event | 2011-03-20 |
| Report Date | 2011-04-11 |
| Date Mfgr Received | 2011-04-11 |
| Date Added to Maude | 2011-06-30 |
| 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 | 0 |
| Event Location | 3 |
| Manufacturer Contact | STACEY STRAND |
| Manufacturer Street | 3M CENTER, BLDG. 275-5W-06 |
| Manufacturer City | ST. PAUL MN 551441000 |
| Manufacturer Country | US |
| Manufacturer Postal | 551441000 |
| Manufacturer Phone | 6517336778 |
| Manufacturer G1 | 3M HEALTH CARE |
| Manufacturer Street | 601 22ND AVE SOUTH |
| Manufacturer City | BROOKINGS SD 57006 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 57006 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3M STERI-STRIP SKIN CLOSURES (REINFORCED) |
| Generic Name | 880.5240 MEDICAL ADHESIVE TAPE AND BANDAGE |
| Product Code | FPX |
| Date Received | 2011-06-20 |
| Model Number | NA |
| Catalog Number | R1547 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M HEALTH CARE |
| Manufacturer Address | ST. PAUL MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-06-20 |