MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-03-12 for BULK SURG STRIP 1/2 X 6 24-5432 manufactured by Codman & Shurtleff, Inc..
[138530081]
(b)(4). It has been reported that the device will be returned for evaluation. Upon receipt of the device or additional relevant information, a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[138530082]
It was reported that the customer received 11 each of the cottonoids which should only be 10 each in a pack. This did not occur intra-operatively. There was no patient harm and no surgical delays.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1226348-2019-10165 |
| MDR Report Key | 8412227 |
| Report Source | DISTRIBUTOR |
| Date Received | 2019-03-12 |
| Date of Report | 2019-02-26 |
| Date of Event | 2019-02-19 |
| Date Mfgr Received | 2019-03-18 |
| Device Manufacturer Date | 2018-01-03 |
| Date Added to Maude | 2019-03-12 |
| 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 | KAREN ANIGBO |
| Manufacturer Street | 11 CABOT BOULEVARD |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 7819715608 |
| Manufacturer G1 | CODMAN & SHURTLEFF, INC. |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02767 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BULK SURG STRIP 1/2 X 6 |
| Generic Name | COTTONOID, PADDIE |
| Product Code | HBA |
| Date Received | 2019-03-12 |
| Returned To Mfg | 2019-03-18 |
| Catalog Number | 24-5432 |
| Lot Number | HN0324 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CODMAN & SHURTLEFF, INC. |
| Manufacturer Address | 325 PARAMOUNT DRIVE RAYNHAM MA 02767 US 02767 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-12 |