MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-07-11 for ENDO CATH II AUTO SUTURE SPECIMEN RETRIEVAL POUCH 15MM 173049 manufactured by Covidien.
| Report Number | MW5088053 |
| MDR Report Key | 8785480 |
| Date Received | 2019-07-11 |
| Date of Report | 2019-06-28 |
| Date of Event | 2019-06-11 |
| Date Added to Maude | 2019-07-12 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 0 |
| Brand Name | ENDO CATH II AUTO SUTURE SPECIMEN RETRIEVAL POUCH 15MM |
| Generic Name | CONTAINER, SPECIMEN MAILER AND STORAGE |
| Product Code | GCI |
| Date Received | 2019-07-11 |
| Model Number | 173049 |
| Lot Number | J8K1975HY |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | 15 HAMPSHIRE ST. MANSFIELD MA 02048 US 02048 |
| Brand Name | ENDO CATH II AUTO SUTURE SPECIMEN RETRIEVAL POUCH 15MM |
| Generic Name | CONTAINER, SPECIMEN MAILER AND STORAGE |
| Product Code | KDT |
| Date Received | 2019-07-11 |
| Model Number | 173049 |
| Lot Number | J8K1975HY |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | 15 HAMPSHIRE ST. MANSFIELD MA 02048 US 02048 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-07-11 |