MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-02-14 for SURGICAL PATTIE, 1/2 X 1/2 80-1400 manufactured by Codman & Shurtleff, Inc..
[100249373]
(b)(4). Upon completion of the investigation a follow up report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[100249374]
It was reported that multiple packs of surgical patties were not detectable by x-ray. The issue occurred during surgery. No reported adverse outcome to the patient or delay in surgery greater than 30 minutes. A similar device was used to complete the procedure. According to the customer, during the procedure, the surgeon viewed the surgical side under fluoroscopy and could not see any of the patties that he had placed. A second pack of patties was used and they were visible. After surgery, a third pack was tested and was also found not to be detectable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1226348-2018-10139 |
| MDR Report Key | 7270806 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-02-14 |
| Date of Event | 2018-01-24 |
| Date Mfgr Received | 2018-03-05 |
| Date Added to Maude | 2018-02-14 |
| 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 | MR JAMES KENNEY |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 5088282726 |
| 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 | 2018-02-14 |
| Returned To Mfg | 2018-02-06 |
| Catalog Number | 80-1400 |
| Lot Number | C58754 |
| 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 | 2018-02-14 |