MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-13 for 7605- 7605 SPG GZ 4X4-16 STR 10FTS manufactured by Covidien.
[136498198]
Additional information has been requested but to date has not yet been received. The incident sample has been requested but to date has not been received for evaluation. If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted. As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
Patient Sequence No: 1, Text Type: N, H10
[136498199]
The customer reports the 4x4 gauze sponges are disintegrating/fraying and sprinkling tiny bits of gauze into the surgical pocket.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1282497-2019-08267 |
| MDR Report Key | 8336014 |
| Date Received | 2019-02-13 |
| Date of Report | 2019-03-21 |
| Date of Event | 2019-02-07 |
| Date Mfgr Received | 2019-02-07 |
| Date Added to Maude | 2019-02-13 |
| 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 | 5084524970 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | 1647 PERKINS RD |
| Manufacturer City | AUGUSTA GA 30913 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30913 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | 7605- 7605 SPG GZ 4X4-16 STR 10FTS |
| Generic Name | FIBER, MEDICAL, ABSORBENT |
| Product Code | FRL |
| Date Received | 2019-02-13 |
| Model Number | 7605 |
| Catalog Number | 7605 |
| Lot Number | 18M083762 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | 1647 PERKINS RD AUGUSTA GA 30913 US 30913 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-13 |