MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2011-05-06 for 3M STERI-STRIP SKIN CLOSURES (REINFORCED) R1547 manufactured by 3m Health Care.
[16413252]
A surgical material services professional at (b)(6) in (b)(6) contacted (b)(6) to report blistering associated with mastisol liquid adhesive. The reporter indicated that there were four pts that had experienced blistering following the use of mastisol liquid adhesive and steri-strips. The skin reactions are being identified during the pts' post-op visits upon removal of the steri-strips. The post-op visits typically occur between 2 - 7 days, following a surgery. The skin reaction of blistering on the incision sites, for the pt in this complaint, occurred post a lap chole procedure. This pt was treated with triamcinolone. Additional medical date: (b)(6) 2011 (info that made this complaint reportable was not provided to 3m until (b)(6) 2011).
Patient Sequence No: 1, Text Type: D, B5
[16658790]
Method: (testing not performed). Results: (product not returned). Conclusions: (no evaluation will be performed).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2110898-2011-00048 |
| MDR Report Key | 2090151 |
| Report Source | 05,07 |
| Date Received | 2011-05-06 |
| Date of Report | 2011-03-08 |
| Date of Event | 2011-03-08 |
| Report Date | 2011-03-08 |
| Date Mfgr Received | 2011-03-08 |
| Date Added to Maude | 2011-05-18 |
| 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 | 6517736778 |
| 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 & BANDAGE |
| Product Code | FPX |
| Date Received | 2011-05-06 |
| 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 | 2011-05-06 |