MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-12-21 for SURGICAL PATTIE, 1/2 X 1/2 80-1400 manufactured by Codman & Shurtleff, Inc..
[131506852]
(b)(4). The device has been returned for evaluation. Upon completion of the investigation, a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[131506853]
As reported by the sales rep, the surgical patties did not show up on the xray while in the patient. There were no reports of delay or patient harm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1226348-2018-10903 |
| MDR Report Key | 8189671 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-12-21 |
| Date of Report | 2018-12-04 |
| Date of Event | 2018-12-03 |
| Date Mfgr Received | 2019-02-01 |
| Date Added to Maude | 2018-12-21 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | SURGICAL PATTIE, 1/2 X 1/2 |
| Generic Name | SURGICAL SPONGE |
| Product Code | HBN |
| Date Received | 2018-12-21 |
| Returned To Mfg | 2018-12-07 |
| Catalog Number | 80-1400 |
| Lot Number | JO455X |
| 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 | 2018-12-21 |