MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-11-23 for STERI-STRIP WOUND CLOSURES (REINFORCED) R1547 manufactured by 3m Health Care.
[1594760]
On 04/13/2009, it was reported that a patient had a vein-stripping procedure where steri-strips were used. On (b) (6)2009, upon follow-up with physician, large fluid filled blisters were noted under most, but not every steri-strip. The tops of the blisters were removed when the steri-strips were removed. The pt reported that other strips were "embedded" in the skin and it was hard to find a corner to lift. Removal was painful. The blisters were treated with hydroquinone compounded by the pharmacy. Scarring has occurred.
Patient Sequence No: 1, Text Type: D, B5
[8580396]
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 | 2110898-2009-00033 |
| MDR Report Key | 1766856 |
| Report Source | 05 |
| Date Received | 2009-11-23 |
| Date of Report | 2009-11-23 |
| Date of Event | 2009-04-13 |
| Date Mfgr Received | 2009-11-12 |
| Device Manufacturer Date | 2009-03-01 |
| Date Added to Maude | 2010-07-24 |
| 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 | KAREN RITTLE, MANAGER |
| Manufacturer Street | 275-5W-06 |
| Manufacturer City | ST. PAUL MN 551441000 |
| Manufacturer Country | US |
| Manufacturer Postal | 551441000 |
| Manufacturer Phone | 6517330074 |
| Manufacturer G1 | 3M HEALTH CARE PLANT - BROOKINGS |
| Manufacturer City | BROOKINGS SD |
| Manufacturer Country | US |
| Single Use | 0 |
| 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 | 2009-11-23 |
| Catalog Number | R1547 |
| Lot Number | UNK |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2009-11-23 |