MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2010-08-30 for STERI-STRIP WOUND CLOSURES (REINFORCED) R1547 manufactured by 3m Healthcare.
[17064463]
On (b)(6)2010, the pt called and reported that she had a breast biopsy and had 2 inch strips placed vertically and she developed blisters under the strips and the strips removed skin when they were removed. She reported that following the breast biopsy, she experienced hot, very painful swelling the size of the palm of her hand. The pt claims insists it's an allergic reaction to latex. The pt claims to have latex allergy. The nurse was contacted and she reported that the doctor didn't think it was an infection two days post op but prescribed an antibiotic and oral benadryl to prophylactically cover either an infection or inflammation. The nurse reported on (b)(6) that the redness was improving.
Patient Sequence No: 1, Text Type: D, B5
[17313432]
Conclusion: the device was not returned to 3m for eval, therefore, no eval or conclusion can be drawn. Product labeling states the expected adverse events 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 | 2110898-2010-00100 |
| MDR Report Key | 1826391 |
| Report Source | 04 |
| Date Received | 2010-08-30 |
| Date of Report | 2010-08-20 |
| Date of Event | 2010-08-03 |
| Date Mfgr Received | 2010-08-04 |
| Date Added to Maude | 2010-09-09 |
| 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 | 3M CENTER, BLDG 0275-05-W-06 |
| Manufacturer City | ST. PAUL MN 55144 |
| Manufacturer Country | US |
| Manufacturer Postal | 55144 |
| Manufacturer Phone | 6517374488 |
| Manufacturer G1 | 3M HEALTHCARE PLANT |
| 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 | 2010-08-30 |
| 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 HEALTHCARE |
| Manufacturer Address | ST. PAUL MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-08-30 |