MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-08-31 for POLY LAM PRODUCTS HMC 8791915 manufactured by Poly Lam Products.
[14506]
Product is allergenic. Rn states product caused difficulty in breathing and lung pain to a total of 3 employees. Employees reported to be without complications.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243621-1995-00676 |
| MDR Report Key | 26425 |
| Date Received | 1995-08-31 |
| Date of Report | 1995-08-15 |
| Date of Event | 1995-07-19 |
| Date Facility Aware | 1995-08-04 |
| Report Date | 1995-08-15 |
| Date Reported to FDA | 1995-08-15 |
| Date Reported to Mfgr | 1995-08-15 |
| Date Added to Maude | 1995-10-04 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | POLY LAM PRODUCTS |
| Generic Name | DRIMOP-SUPERABSORBENT |
| Product Code | FKG |
| Date Received | 1995-08-31 |
| Catalog Number | HMC 8791915 |
| Lot Number | 95035 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 27099 |
| Manufacturer | POLY LAM PRODUCTS |
| Manufacturer Address | 90 EARHART DR STE 1 WILLIAMSVILLE NY 14221 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1995-08-31 |