MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-01-28 for GELFOAM manufactured by Pfizer, Inc. (device).
| Report Number | 1810189-2020-00002 |
| MDR Report Key | 9637302 |
| Report Source | CONSUMER |
| Date Received | 2020-01-28 |
| Date of Report | 2019-04-08 |
| Date Added to Maude | 2020-01-28 |
| 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 | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS STELLA PIETRAFESA |
| Manufacturer Street | 235 E42ND STREET |
| Manufacturer City | NEW YORK NY 10017 |
| Manufacturer Country | US |
| Manufacturer Postal | 10017 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GELFOAM |
| Generic Name | SPONGE, STERILE; CLASS III |
| Product Code | LMF |
| Date Received | 2020-01-28 |
| Lot Number | KK507 |
| Device Expiration Date | 2019-05-01 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PFIZER, INC. (DEVICE) |
| Manufacturer Address | 7000 PORTAGE ROAD KALAMAZOO MI 49001 US 49001 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-28 |