MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 1998-06-22 for CODMAN BICOL SPONGE 80-1460 manufactured by Johnson & Johnson Professional, Inc..
[95423]
A bicol collagen sponge was utilized during a recent craniotomy. When the bicol sponge removal was attempted, great difficulty was encountered. According to the surgeon, the bicol sponge appeared to be in good condition upon application, and that all appeared normal during use. When removal was attempted the bicol sponge tore into many pieces and adhered to the adjacent tissue. This adherence caused significant trauma when removed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219655-1998-00113 |
| MDR Report Key | 173290 |
| Report Source | 06 |
| Date Received | 1998-06-22 |
| Date of Report | 1998-06-22 |
| Date Mfgr Received | 1998-05-25 |
| Device Manufacturer Date | 1997-04-01 |
| Date Added to Maude | 1998-06-23 |
| 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 | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CODMAN BICOL SPONGE |
| Generic Name | SURGICAL SPONGE |
| Product Code | GER |
| Date Received | 1998-06-22 |
| Model Number | NA |
| Catalog Number | 80-1460 |
| Lot Number | DP285 |
| ID Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | U |
| Device Sequence No | 1 |
| Device Event Key | 168485 |
| Manufacturer | JOHNSON & JOHNSON PROFESSIONAL, INC. |
| Manufacturer Address | 325 PARAMOUNT DR RAYNHAM MA 027670350 US |
| Baseline Brand Name | CODMAN BICOL SPONGE |
| Baseline Generic Name | SURGICAL SPONGE |
| Baseline Model No | NA |
| Baseline Catalog No | 80-1460 |
| Baseline ID | NA |
| Baseline Device Family | BICOL SPONGE |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1998-06-22 |