MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-05-02 for SURGICAL PATTIE, 1/2 X 1/2 80-1400 manufactured by Codman & Shurtleff, Inc..
[74259837]
(b)(4). Upon completion of the investigation, a follow up report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[74259838]
As reported by cardinal health, a 10 pack of patties, when opened, contained 9. Per affiliate; please supply the lot number of the described device - c36836. Did this event occur intra-operatively? No. Did the reported event cause any delays in the procedure or surgery over 30 minutes? Just opened new pack. What action was taken to resolve the issue? Opened new pack. Were there any adverse consequences to the patient? None. Please verify if the device is being returned for evaluation. Yes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1226348-2017-10301 |
| MDR Report Key | 6538843 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-05-02 |
| Date of Event | 2017-04-07 |
| Date Mfgr Received | 2017-06-28 |
| Date Added to Maude | 2017-05-02 |
| 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 | 2017-05-02 |
| Returned To Mfg | 2017-04-24 |
| Catalog Number | 80-1400 |
| Lot Number | C36836 |
| 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 | 2017-05-02 |