MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2009-11-02 for 3M STERI-STRIP WOUND CLOSURES R1547 manufactured by 3m.
[1331121]
The following was reported by pt's wife: pt had a third pacemaker implant and incision was closed using steri-strips. The next day, large blisters were seen at the surgical site. Attending physician attributed the blisters to an allergic reaction and prescribed keflex prophylactically to prevent infection. A pocket hematoma developed on (b)(6)2009 and the incision was drained and an antibiotic pouch placed around the pacemaker: site closed with staples. Pt discharged on (b)(6)2009. Staples removed (b)(6)2009.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2110898-2009-00032 |
| MDR Report Key | 1523708 |
| Report Source | 04 |
| Date Received | 2009-11-02 |
| Date of Report | 2009-11-02 |
| Date of Event | 2009-08-18 |
| Date Mfgr Received | 2009-10-05 |
| Date Added to Maude | 2010-08-21 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | KAREN RITTLE, MGR |
| 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 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 WOUND CLOSURES |
| Generic Name | WOUND CLOSURES |
| Product Code | FPX |
| Date Received | 2009-11-02 |
| Model 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 |
| Manufacturer Address | ST. PAUL MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2009-11-02 |