MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,06,07 report with the FDA on 2012-06-06 for SHUR-CLENS - WOUND CLEANSER 121222 manufactured by Convatec.
[2669459]
Stated problem: info from this complaint was obtained from chemtrec emergency incident report #2012-05-06-00024. Date of incident was (b)(6) 2012 at 11:43 am, reported by a coworker who stated that a coworker got the product in their eye. Coworker was in emergency room and msds was provided. Further f/ with chemtrec to obtain additional info regarding the 'consumer', product usage and outcome but very limited info was provided to chemtrec and 'consumer' did not f/u as requested. From a clinical perspective, additional info was not received on this case and we never got the medical report detailing the er visit treatment. However from earlier telephone conversation that we had with the co-worker who accompanied the pt to the er, we are deeming this a serious ae. This is based on the fact that the event necessitated a visit to the er and treatment was rendered therein, possibly to prevent a permanent impairment to bodily structure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243969-2012-00036 |
| MDR Report Key | 2612712 |
| Report Source | 04,06,07 |
| Date Received | 2012-06-06 |
| Date of Report | 2012-05-07 |
| Date of Event | 2012-05-06 |
| Date Mfgr Received | 2012-05-07 |
| Date Added to Maude | 2012-06-13 |
| 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 | ADRIENNE MCNALLY |
| Manufacturer Street | 200 HEADQUARTERS PARK DR. |
| Manufacturer City | SKILLMAN NJ 08558 |
| Manufacturer Country | US |
| Manufacturer Postal | 08558 |
| Manufacturer Phone | 9089042630 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SHUR-CLENS - WOUND CLEANSER |
| Generic Name | SHUR CLENS WOUND CLEANSER |
| Product Code | KOY |
| Date Received | 2012-06-06 |
| Model Number | NA |
| Catalog Number | 121222 |
| Lot Number | UNK |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONVATEC |
| Manufacturer Address | 200 HEADQUARTERS PARK DR. SKILLMAN NJ 08558 US 08558 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2012-06-06 |