MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-06-14 for TEMPERATURE THERAPY PAD TP22G NA manufactured by Stryker Corp Dba Gaymar.
[2083165]
It was reported by the customer that the pad is leaking. No pt involvement or adverse consequences were reported. Customer stated they received a call from vet clinic that tp22g was leaking. Customer wants replacement of pad after results are in.
Patient Sequence No: 1, Text Type: D, B5
[9012991]
Unit not yet returned for eval, so severity of leak has not been determined. A f/u report will be issued as necessary based upon investigation results.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1313850-2011-00141 |
| MDR Report Key | 2135239 |
| Report Source | 06 |
| Date Received | 2011-06-14 |
| Date of Report | 2011-05-17 |
| Date of Event | 2011-05-17 |
| Date Mfgr Received | 2011-05-17 |
| Date Added to Maude | 2011-08-03 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | RENATA SILA |
| Manufacturer Street | 3800 E. CENTRE AVE. |
| Manufacturer City | PORTAGE MI 49002 |
| Manufacturer Country | US |
| Manufacturer Postal | 49002 |
| Manufacturer Phone | 2693896689 |
| Manufacturer G1 | STRYKER CORP DBA GAYMAR |
| Manufacturer Street | 10 CENTRE DR. |
| Manufacturer City | ORCHARD PARK NY 14127 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 14127 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TEMPERATURE THERAPY PAD |
| Generic Name | TEMPERATURE THERAPY PAD |
| Product Code | FOH |
| Date Received | 2011-06-14 |
| Model Number | TP22G |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER CORP DBA GAYMAR |
| Manufacturer Address | ORCHARD PARK NY 14127 US 14127 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-06-14 |