MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-03-14 for ABSORBABLE PIN (TAPERED PIN) REF: 84-1070 manufactured by Johnson & Johnson.
[178332]
Physician contacted surgery center to state "the pt had an allergic reaction" to abosorbable pins that were used during podiatric surgery. Subsequent to this reaction, cultures were obtained by the surgeon and the pins were removed. The pt has had continuing problems and has had continued follow-up apointments with the surgeon. The same products were used for a similar procedure on the right foot. Procedure: arthroplasty 2nd-5th toes l foot with osteotomy 5th toe and capsulotomy of 2nd-5th toes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 269429 |
| MDR Report Key | 269429 |
| Date Received | 2000-03-14 |
| Date of Report | 2000-03-13 |
| Date of Event | 2000-03-03 |
| Report Date | 2000-03-13 |
| Date Reported to FDA | 2000-03-13 |
| Date Added to Maude | 2000-03-17 |
| 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 |
| 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 | ABSORBABLE PIN (TAPERED PIN) |
| Generic Name | ABSORBABLE PIN (TAPERED PIN) |
| Product Code | MBJ |
| Date Received | 2000-03-14 |
| Model Number | REF: 84-1070 |
| Catalog Number | REF: 84-1070 |
| Lot Number | LA9973 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 60 DAY |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 260837 |
| Manufacturer | JOHNSON & JOHNSON |
| Manufacturer Address | * RAYNHAM MA 027670350 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2000-03-14 |