MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2018-09-03 for WINGS QUILTED MVP 30X36 P3036MVP manufactured by Covidien.
[119024825]
The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event. If additional information or the sample is received, the investigation will be reopened and responded to accordingly.
Patient Sequence No: 1, Text Type: N, H10
[119024826]
The customer reports they are having issues with it not absorbing the fluids and has torn on some patients.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1033903-2018-00201 |
| MDR Report Key | 7840516 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2018-09-03 |
| Date of Report | 2018-09-01 |
| Date of Event | 2018-08-02 |
| Date Mfgr Received | 2018-08-02 |
| Date Added to Maude | 2018-09-03 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | EDWARD ALMEIDA |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5084524151 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | 525 NORTH EMERALD RD |
| Manufacturer City | GREENWOOD SC 29646 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 29646 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WINGS QUILTED MVP 30X36 |
| Generic Name | GARMENT, PROTECTIVE, FOR INCONTINENCE |
| Product Code | EYQ |
| Date Received | 2018-09-03 |
| Model Number | P3036MVP |
| Catalog Number | P3036MVP |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | 525 NORTH EMERALD RD GREENWOOD SC 29646 US 29646 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-09-03 |