MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2014-08-13 for SHOULDER P.A.D II, ABDUCTION DEVICE M 11630006 manufactured by Deroyal Intercontinental S.l.r.
[4734076]
The patient's skin broke out in a rash after using the product. Every part of the skin that the sling has touched broke out in a rash.
Patient Sequence No: 1, Text Type: D, B5
[11920950]
Investigation findings: the complaint sample was returned, the product shows sign of wear/use (has some debris/hair on it) no manufacturing issue was found. I have attached the bom for the (b)(4) along with the component evaluation form, msds and technical data sheet for the sling raw material. Correction: replacement sent of the shoulder pad iii. Root cause analysis: unable to determine, several factors including heat, medication and ones own sensitivity to certain chemicals/materials can cause an allergic reaction. Corrective action and/or systemic correction action taken: no action required at this time, no manufacturing issue found, i do not recall any like complaints for this item. No further information available at this time. Will provide follow ups if additional information becomes available.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006851902-2014-00001 |
| MDR Report Key | 4055504 |
| Report Source | 04 |
| Date Received | 2014-08-13 |
| Date of Report | 2014-08-12 |
| Date of Event | 2014-07-09 |
| Date Facility Aware | 2014-07-16 |
| Report Date | 2014-08-12 |
| Date Mfgr Received | 2014-07-16 |
| Date Added to Maude | 2014-09-08 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 200 DEBUSK LANE |
| Manufacturer City | POWELL TN 37849 |
| Manufacturer Country | US |
| Manufacturer Postal | 37849 |
| Manufacturer Phone | 8653622333 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SHOULDER P.A.D II, ABDUCTION DEVICE M |
| Generic Name | SLING ARM |
| Product Code | ILI |
| Date Received | 2014-08-13 |
| Returned To Mfg | 2014-07-25 |
| Catalog Number | 11630006 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEROYAL INTERCONTINENTAL S.L.R |
| Manufacturer Address | KM 7 AUTOPISTA JOAQUIN BALAGUER PISANO FREE ZONE, BUILDING 18 SANTIAGO DO |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-08-13 |