MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 1996-12-10 for ORTHOSORB ABSORBABLE UNK manufactured by Johnson & Johnson Professional, Inc..
[18331633]
Co received medwatch report no. 1010284 from the food & drug admin concerning an absorbable pin. According to the report "device was used to stabilize a bone. Pt was suffering from continuous swelling. X-rays were taken and it revealed extreme resorption of metatarsal head secondary to the user of the device".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219655-1996-00045 |
| MDR Report Key | 54261 |
| Report Source | 00 |
| Date Received | 1996-12-10 |
| Date of Report | 1996-12-10 |
| Date of Event | 1996-09-11 |
| Date Reported to FDA | 1996-11-18 |
| Date Mfgr Received | 1996-12-03 |
| Date Added to Maude | 1996-12-11 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ORTHOSORB ABSORBABLE |
| Generic Name | ABSORBABLE PIN |
| Product Code | MBJ |
| Date Received | 1996-12-10 |
| Model Number | NA |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | NA |
| Operator | UNKNOWN |
| Device Availability | N |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 50900 |
| Manufacturer | JOHNSON & JOHNSON PROFESSIONAL, INC. |
| Manufacturer Address | 325 PARAMOUNT DRIVE RAYNHAM MA 02767 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1996-12-10 |