MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2010-07-26 for STERI-STRIP WOUND CLOSURES (REINFORCED) R1547 manufactured by 3m Health Care.
[1359037]
Customer reported the she had a hysterectomy on (b)(6) 2009, with steri-strips on the incision covered by a bulky dressing framed with durapore tape. She said that she had dime size blisters on both ends of the strip on the right end of the incision. When the doctor tried to remove it, her skin came off with the tape. She said it was worse on the upper edge on the left side. She said she has black skin, and since september has used kelocote, cocoa butter, etc. , but still has dark spots. She said she tried ambi, an otc bleaching cream for black skin and it worked a little but only in the center. She mentioned when she was (b)(6) she got burned on a pot, blistered, and now (b)(6) still has a dark spot.
Patient Sequence No: 1, Text Type: D, B5
[8585795]
Conclusion: the device was not returned to 3m for evaluation, therefore, no evaluation or conclusion can be drawn. Product labeling states the expected aes with product use in the warning section, shown below: warnings. The development of postoperative edema may cause skin shearing, skin blistering, or loss of tape adhesion to occur at either end of the strip. Application of any surgical tape or adhesive skin closure may result in skin stripping upon removal. As with all adhesive products applied to the skin, a small percentage of individuals may experience hypopigmentation or hyperpigmentation following removal. Occasional cases of mild acne and folliculitis have been observed in testing on healthy volunteers.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2110898-2010-00090 |
| MDR Report Key | 1780852 |
| Report Source | 04 |
| Date Received | 2010-07-26 |
| Date of Report | 2010-07-22 |
| Date of Event | 2010-07-12 |
| Date Mfgr Received | 2010-07-12 |
| Date Added to Maude | 2011-04-18 |
| 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 | 0 |
| Manufacturer Contact | DAISY SIN |
| Manufacturer Street | 275-5W-06 |
| Manufacturer City | SAINT PAUL MN 551441000 |
| Manufacturer Country | US |
| Manufacturer Postal | 551441000 |
| Manufacturer Phone | 6517374488 |
| Manufacturer G1 | 3M HEALTH CARE PLANT - BROOKINGS |
| Manufacturer City | BROOKINGS SD |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STERI-STRIP WOUND CLOSURES (REINFORCED) |
| Generic Name | NONE |
| Product Code | FPX |
| Date Received | 2010-07-26 |
| 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 | SAINT PAUL MN 55133100 US 55133 1000 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-07-26 |