MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,04,05,06,07 report with the FDA on 2011-03-24 for POWERPRO STERILE TRANSFER CASE, LARGE PRO3110 manufactured by Conmed Linvatec.
[1885832]
The customer reported the lid was broken at the hinges. There was no report of pt injury and/or adverse outcome. A subsequent review of this complaint found that the sterile barrier may have been compromised.
Patient Sequence No: 1, Text Type: D, B5
[9223518]
The product was not returned to conmed linvatec for eval. Product history shows this device was outside its warranty. A two year review of complaint history for this device showed there have been no serious injuries or deaths related to the reported problem. The product ifu warns: inspect the sterile transfer battery case for any damage, such as: cracks in the case or damaged, broken, or worn o-rings, latch, and/or hinge. If damage is found, do not use. Sterility may be compromised and pt infection may occur.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1017294-2011-00006 |
| MDR Report Key | 2038591 |
| Report Source | 01,04,05,06,07 |
| Date Received | 2011-03-24 |
| Date of Report | 2011-03-24 |
| Date Mfgr Received | 2009-07-09 |
| Device Manufacturer Date | 2008-08-01 |
| Date Added to Maude | 2011-04-27 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | BRENDA JOHNSON |
| Manufacturer Street | 11311 CONCEPT BLVD. |
| Manufacturer City | LARGO FL 33773 |
| Manufacturer Country | US |
| Manufacturer Postal | 33773 |
| Manufacturer Phone | 7273995515 |
| Manufacturer G1 | CONMED LINVATEC |
| Manufacturer Street | 11311 CONCEPT BLVD. |
| Manufacturer City | LARGO FL 33773 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33773 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | POWERPRO STERILE TRANSFER CASE, LARGE |
| Generic Name | SAW, POWERED, AND ACCESSORIES |
| Product Code | FCO |
| Date Received | 2011-03-24 |
| Catalog Number | PRO3110 |
| Lot Number | BBD77391 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONMED LINVATEC |
| Manufacturer Address | LARGO FL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-03-24 |