MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-12-09 for ORTHOSORB * 84-1052 manufactured by Johnson & Johnson Professional Inc..
[21252230]
The pt had a hammertoe plasty of second toe performed two weeks ago. The toe became markedly inflamed and irritated. Pt was admitted for antibiotic therapy, debridement of second toe, and removal of implant due to probable allergic reaction to the synthetic implant. A stainless steel pin was used to transfix both arthroplasty sites.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 138606 |
| MDR Report Key | 138606 |
| Date Received | 1997-12-09 |
| Date of Report | 1997-12-05 |
| Date of Event | 1997-10-24 |
| Report Date | 1997-11-24 |
| Date Reported to Mfgr | 1997-12-05 |
| Date Added to Maude | 1997-12-19 |
| 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 | ORTHOSORB |
| Generic Name | ABSORBABLE PIN, 1.3 MM |
| Product Code | MBJ |
| Date Received | 1997-12-09 |
| Model Number | * |
| Catalog Number | 84-1052 |
| Lot Number | * |
| ID Number | 138BE |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 15 DAY |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 135364 |
| Manufacturer | JOHNSON & JOHNSON PROFESSIONAL INC. |
| Manufacturer Address | 325 PARAMOUNT DR. RAYNHAM MA 02767 US |
| Baseline Brand Name | ORTHOSORB ABSORBABLE PIN |
| Baseline Generic Name | ABSORBABLE PIN |
| Baseline Model No | NA |
| Baseline Catalog No | 84-1052 |
| Baseline ID | * |
| Baseline Device Family | ORTHOSORB ABSORBABLE PIN |
| Baseline Shelf Life Contained | * |
| Baseline Shelf Life [Months] | 60 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K864912 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 1997-12-09 |