MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-05-19 for SURGICAL PATTIE, 1/2 X 1/2 80-1400 manufactured by Codman & Shurtleff, Inc..
[75557343]
Udi: (b)(4). Upon completion of the investigation a follow up report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[75557344]
Neurosurgeon has reported that the pattie left microfibers behind in the patient, visible under microscope during surgery. No reported delay in surgery greater than 30 minutes.
Patient Sequence No: 1, Text Type: D, B5
[76441349]
Device was returned. The dhr/manufacturing lot traveler was pulled and reviewed for lot h43025. All information on the traveler indicates that the product was produced within specifications. Upon completion of the investigation a followup report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[96163242]
Upon completion of the investigation it was noted that the product is documented in the ifu as low linting. While there is variation inherent in our manufacturing process of the cottonoid material, our objective is to produce product with the least possible amount of linting. Therefore lot to lot variation in the cottonoid process may result in lots that lint more or less than the norm. "linting" can also come from the quality of the edge cut from the slitting process, but the parts received did not show that issue. Based on the results of this investigation no further action is required. Trends will be monitored for this and similar complaints. At the present time this complaint is closed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226348-2017-10338 |
| MDR Report Key | 6578609 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-05-19 |
| Date of Event | 2017-04-12 |
| Date Mfgr Received | 2017-06-15 |
| Date Added to Maude | 2017-05-19 |
| 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 | 2017-05-19 |
| Returned To Mfg | 2017-05-24 |
| Catalog Number | 80-1400 |
| Lot Number | H43025 |
| 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 | 1. Required No Informationntervention | 2017-05-19 |