MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-11-10 for STERI-STRIP WOUND CLOSURE SYSTEM W8512 manufactured by 3m Company.
[2800331]
On (b)(4) 2009, it was reported that a pt had a breast biopsy and incision was closed with steri-strips. Blisters developed and then cellulitis which was treated with 4 im rocephin injections followed by 18 days of bactrim and on (b)(6) 2009, clindamycin. Pt lumpectomy has been delayed.
Patient Sequence No: 1, Text Type: D, B5
[10224846]
Product labeling clearly state 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 of 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 | 2110898-2009-00035 |
| MDR Report Key | 2704539 |
| Report Source | 05 |
| Date Received | 2009-11-10 |
| Date of Report | 2009-11-10 |
| Date of Event | 2009-09-11 |
| Date Mfgr Received | 2009-10-12 |
| Device Manufacturer Date | 2009-03-01 |
| Date Added to Maude | 2012-08-21 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | KAREN RITTLE, REGULATORY MGR |
| Manufacturer Street | 3M CENTER, BLDG. 275-5W-06 |
| Manufacturer City | ST. PAUL MN 551441000 |
| Manufacturer Country | US |
| Manufacturer Postal | 551441000 |
| Manufacturer Phone | 6517330074 |
| Manufacturer G1 | 3M HEALTH CARE PLANT |
| 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 CLOSURE SYSTEM |
| Generic Name | NONE |
| Product Code | FPX |
| Date Received | 2009-11-10 |
| Model Number | W8512 |
| Lot Number | 2014-03AL |
| Device Expiration Date | 2014-03-31 |
| 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 COMPANY |
| Manufacturer Address | 3M CENTER, BLDG. 275-5W-06 ST. PAUL MN 55144100 US 55144 1000 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-11-10 |