MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-01 for COVIDIEN RETRIEVAL POUCH REF 173050G manufactured by Covidien.
[116053953]
Partial piece of lap chole bag or dilator cannula broke off and retained during surgery. Alleged abscess and lengthened sickness of patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5078785 |
| MDR Report Key | 7742650 |
| Date Received | 2018-08-01 |
| Date of Report | 2018-07-30 |
| Date of Event | 2018-07-12 |
| Date Added to Maude | 2018-08-02 |
| 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 | 3 |
| 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 | COVIDIEN RETRIEVAL POUCH |
| Generic Name | SPEC. RETRIEVAL POUCH |
| Product Code | KGY |
| Date Received | 2018-08-01 |
| Model Number | REF 173050G |
| Lot Number | J8C0783MX |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | MANSFIELD MA 02048 US 02048 |
| Brand Name | VERSASTEP PLUS CANNULA DILATOR |
| Generic Name | DILATOR AND CANNULA |
| Product Code | GCJ |
| Date Received | 2018-08-01 |
| Model Number | REF VS101011P |
| Lot Number | J5B0498X |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | MANSFIELD MA 02048 US 02048 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2018-08-01 |