MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2013-08-23 for CURITY IODOFORM STRIPS 1X5 STRL 7833 manufactured by Covidien.
[16058079]
It was reported to covidien on (b)(4) 2013 that a customer had an issue with packing strip. The customer states that a pt cavity was repacked by the surgery resident with 1 inch packing strips. The strips became lodged in the cavity when the packing strips were to be changed. The pt was taken to surgery and a 4 inch incision was created and the strips were removed using hemostats. This was when the surgeon discovered that the 1 inch packing strips had broken into 4 separate pieces.
Patient Sequence No: 1, Text Type: D, B5
[16426754]
An investigation is currently underway, upon completion the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1018120-2013-00004 |
| MDR Report Key | 3375796 |
| Report Source | 06,07 |
| Date Received | 2013-08-23 |
| Date of Report | 2013-07-25 |
| Report Date | 2013-07-25 |
| Date Reported to Mfgr | 2013-07-25 |
| Date Mfgr Received | 2013-07-25 |
| Date Added to Maude | 2013-11-21 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | ARMANDO BOTELHO |
| Manufacturer Street | 15 HAMPSHIRE ST |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5082616387 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | 1430 MARVIN GRIFFIN RD. |
| Manufacturer City | AUGUSTA GA 30906 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30906 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CURITY IODOFORM STRIPS 1X5 STRL |
| Generic Name | PACKING STRIPS |
| Product Code | GEL |
| Date Received | 2013-08-23 |
| Model Number | 7833 |
| Catalog Number | 7833 |
| Lot Number | 130000417462X |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | 1430 MARVIN GRIFFIN RD. AUGUSTA GA 30906 US 30906 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-08-23 |