FDA Adverse Event
Other
Summary report: N
3M STERI-STRIP WOUND CLOSURES
MDR report key: 1523708
·
Received November 2, 2009
Report
- Report Number
- 2110898-2009-00032
- Event Type
- Other
- Date Received
- November 2, 2009
- Date of Event
- August 18, 2009
- Report Date
- November 2, 2009
- Manufacturer
- 3M
- Product Code
- FPX
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 3M STERI-STRIP WOUND CLOSURES | WOUND CLOSURES | FPX | 3M | R1547 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Other |