MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-09-24 for WEDGIE - 3"X4"X5" 91014 manufactured by Philips Medical Systems.
[5192659]
The customer reported mold on the wedgie product. No pt incident/injury was reported.
Patient Sequence No: 1, Text Type: D, B5
[12506304]
(b)(4). The customer reported mold on the wedgie product. No pt incident/injury was reported. This complaint is being reported, as no material is available for eval to confirm that there is no mold in/on the product. There is no current evidence that mold will grow inside the wedgie product (gel matrix). There is no evidence of gel "sweating" through the bladder for mold to grow on the outside of the bladder. The bladder is made of vinyl, which is a different material from that used for the gel-e donut product. No product malfunction can be confirmed/determined, as no material is available for eval/testing.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1218950-2014-07330 |
| MDR Report Key | 4309731 |
| Report Source | 06 |
| Date Received | 2014-09-24 |
| Date of Report | 2014-06-17 |
| Date Mfgr Received | 2014-06-17 |
| Date Added to Maude | 2014-12-15 |
| 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 | NANCY ATAIDE |
| Manufacturer Street | 3000 MINUTEMAN RD. |
| Manufacturer City | ANDOVER MA 01810 |
| Manufacturer Country | US |
| Manufacturer Postal | 01810 |
| Manufacturer Phone | 9786597429 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WEDGIE - 3"X4"X5" |
| Product Code | FMP |
| Date Received | 2014-09-24 |
| Model Number | 91014 |
| Lot Number | LOT CODE NOT PROVIDED - NO |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS MEDICAL SYSTEMS |
| Manufacturer Address | 3000 MINUTEMAN RD. ANDOVER MA 01810 US 01810 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-09-24 |