MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2010-12-21 for 90018107 LAP SPG P-W 18X18 NON-STR 6822 manufactured by Grand Medical.
[1783508]
It was reported to covidien on (b)(6) 2010 that a customer had an issue with a lap sponge. The customer reported that the lap sponge unraveled and frayed. This was noticed during surgery by the physician/operating room scrub technicians. Any loose threads were removed from the pts.
Patient Sequence No: 1, Text Type: D, B5
[8925743]
Submit date: (b)(4) 2010. An investigation is currently underway, upon completion the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1282497-2010-00023 |
| MDR Report Key | 1945274 |
| Report Source | 06,07 |
| Date Received | 2010-12-21 |
| Date of Report | 2010-12-01 |
| Report Date | 2010-12-01 |
| Date Reported to Mfgr | 2010-12-01 |
| Date Mfgr Received | 2010-12-01 |
| Date Added to Maude | 2011-02-08 |
| 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 | 0 |
| Event Location | 3 |
| Manufacturer Contact | SHARON SELBY |
| Manufacturer Street | 15 HAMPSHIRE ST. |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5082618488 |
| Manufacturer G1 | GRAND MEDICAL |
| Manufacturer Street | 7222 ERTEL LANE |
| Manufacturer City | HOUSTON TX 77040 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 77040 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 90018107 LAP SPG P-W 18X18 NON-STR |
| Generic Name | LAP SPONGE |
| Product Code | GEL |
| Date Received | 2010-12-21 |
| Model Number | 6822 |
| Catalog Number | 6822 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GRAND MEDICAL |
| Manufacturer Address | 7222 ERTEL LANE HOUSTON TX 77040 US 77040 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-12-21 |