MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-10-12 for GELFOAM ABSORBABLE GELATIN SPONGE SIZE 50 manufactured by Pharmacia/upjohn.
[2285026]
Gelfoam absorbable gelatin sponge size 50 difficult to tear open and would adhere to the sponge. The packaging looked old. Lot #obfax, exp: 10/2013.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5022664 |
| MDR Report Key | 2299789 |
| Date Received | 2011-10-12 |
| Date of Report | 2011-10-12 |
| Date of Event | 2011-10-03 |
| Date Added to Maude | 2011-10-20 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | PHARMACIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GELFOAM ABSORBABLE GELATIN SPONGE SIZE 50 |
| Generic Name | ABSORBABLE GELATIN SPONGE |
| Product Code | JXZ |
| Date Received | 2011-10-12 |
| Lot Number | OBFAX |
| Device Expiration Date | 2013-10-31 |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHARMACIA/UPJOHN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-10-12 |