MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 1998-01-16 for ORTHOSORB ABSORBABLE PIN 84-1052 manufactured by Johnson & Johnson Professionals, Inc..
[86645]
The pt had a hammertoe plasty of the second toe. The toe became markedly inflamed and irritated. Pt was admitted to the hosp for antibiotic therapy, debridement of the second toe, and removal of implant due to probable allergic reaction to the synthetic implant. A stainless steel pin was used to transfix the arthroplasty sites.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219655-1998-00007 |
| MDR Report Key | 144275 |
| Report Source | 06 |
| Date Received | 1998-01-16 |
| Date of Report | 1998-01-16 |
| Date of Event | 1997-10-24 |
| Date Mfgr Received | 1997-12-17 |
| Date Added to Maude | 1998-01-20 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ORTHOSORB ABSORBABLE PIN |
| Generic Name | ABSORBABLE PIN |
| Product Code | MBJ |
| Date Received | 1998-01-16 |
| Model Number | NA |
| Catalog Number | 84-1052 |
| Lot Number | 138BE |
| ID Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 140696 |
| Manufacturer | JOHNSON & JOHNSON PROFESSIONALS, INC. |
| Manufacturer Address | 325 PARAMOUNT DRIVE 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 | 1998-01-16 |