MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-13 for DRY SKIN SCRUB TRAY W/15 4"X4" 41522 manufactured by Covidien.
[145112729]
Additional information has been requested but to date has not yet been received. 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. As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product. 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
[145112730]
The customer reports that the 4x4 gauze within the kit were not woven and completely fell apart.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612030-2019-02173 |
| MDR Report Key | 8604272 |
| Date Received | 2019-05-13 |
| Date of Report | 2019-05-13 |
| Date of Event | 2019-05-02 |
| Date Mfgr Received | 2019-05-02 |
| Date Added to Maude | 2019-05-13 |
| 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 | JILL SARAIVA |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5086183640 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | CALLE 9 SUR NO. 125 CUIDAD IND |
| Manufacturer City | TIJUANA 22500 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 22500 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | DRY SKIN SCRUB TRAY W/15 4"X4" |
| Generic Name | KIT, SURGICAL INSTRUMENT, DISPOSABLE |
| Product Code | KDD |
| Date Received | 2019-05-13 |
| Model Number | 41522 |
| Catalog Number | 41522 |
| Lot Number | 1732672064 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | CALLE 9 SUR NO. 125 CUIDAD IND TIJUANA 22500 MX 22500 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-13 |