MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-02-05 for STERI STRIP UNK manufactured by 3m.
[19527495]
The patient had prostatic robotic surgery and was admitted. Blisters around his lap sites although his incision sites were ok. The blisters became worse after discharge requiring a visit to the surgeon's office to have them drained. The patient returned for another procedure the following week with concerns regarding what may have caused the blisters. The surgeon's office stated they believed the blisters were an allergic reaction to the steri strips. The patient will list steri strips as an allergy in the future.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1601002 |
| MDR Report Key | 1601002 |
| Date Received | 2010-02-05 |
| Date of Report | 2010-02-05 |
| Date of Event | 2010-01-19 |
| Report Date | 2010-02-05 |
| Date Reported to FDA | 2010-02-05 |
| Date Added to Maude | 2010-02-17 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STERI STRIP |
| Generic Name | TAPE, SKIN CLOSURE |
| Product Code | FPX |
| Date Received | 2010-02-05 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | * |
| Device Availability | N |
| Device Age | 1 DY |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M |
| Manufacturer Address | 3M CENTER, BLDG. 275-5W-06 SAINT PAUL MN 55144 US 55144 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2010-02-05 |